MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that non preloaded toric ii intraocular lens (iol) were explanted from the patient's eyes both eyes (ou).It was noted that there was no product issue.However, it was learnt that the lenses were replaced with non johnson and johnson light adjustable lenses per patient's request.The patient is doing well.There was no patient injury.Patient is not experiencing any issues at this time.No other information is available.
Additional Manufacturer Narrative
Section a3b: unknown, information not provided.Section b3: date of event: unknown, not provided.Section d6a: if implanted, give date: unknown, information not provided.Section d6b: if explanted, give date: unknown, information not provided.Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review it was noted that in the initial report submitted, patient age, gender, cisgender were provided incorrectly.Also, date of event was provided in section b3 but it should have been left blank as noted in h10 text of initial report initially submitted.Therefore, those information have been corrected in this supplemental report.The following fields are updated accordingly.Section a2: age: 77 yrs.Old.Section a3: sex: male.Section a3: gender: cisgender: man/boy.Additional information: new information received that there was no other adverse event.And that the report in the initial report submitted was for the suspect lens in right eye of patient.A separate report was submitted for the other suspect iol related to the left eye.Moreover, implant date was (b)(6) 2024 and explant date was (b)(6) 2024.Fields below updated.Section d6a: if implanted, give date: (b)(6) 2024.Section d6b: if explanted, give date: (b)(6) 2024.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19455906
• Report Number: 3012236936-2024-000159
• Device Sequence Number: 7907617
• Product Code: HQL
• UDI-Device Identifier: 05050474665378
• UDI-Public: (01)05050474665378(17)260927
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2026
• Device Model Number: ZCU600
• Device Catalogue Number: ZCU600U155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White